Diabetes Drug Recalled Over Foreign Substance

Sun Pharmaceutical Industries Inc is voluntarily recalling 50,868 bottles of metformin hydrochloride extended-release tablets due to the presence of a foreign substance identified as activated carbon. The recall was included in the May 19, 2021, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects 500-count bottles of metformin hydrochloride extended-release tablets, 500 mg (NDC 62756-142-02), from lots JKX2749A, JKX2803A, JKX2805A, JKX806A, JKX2945A, JKX2946A, JXK2947A, JKX2948A, JKX2952A, JKX2953A, JKX2954A, and JKX3224A (Exp. 6/23); and JKX3211A and JKX3212A (Exp. 7/23). The tablets were manufactured by Sun Pharmaceutical Industries Ltd, Gujarat, India, and distributed by Sun Pharmaceutical Industries, Cranbury, NJ, throughout the United States. 

Sun Pharmaceutical Industries voluntarily initiated the recall May 4, 2021. The FDA designated the recall Class II on May 7, 2021. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists. 

Metformin is a prescription medication used to help control blood sugar levels in people with type 2 diabetes.

—Jolynn Tumolo